IMPORTANT SAFETY INFORMATION: WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. View more

GETTING TREATMENT

Pompe disease is a chronic disorder, in which the body does not produce enough of the acid α-glucosidase (GAA) enzyme on its own. Lumizyme® (alglucosidase alfa) is a medication administered by intravenous infusion to provide a replacement for the missing enzyme directly into the bloodstream. Lumizyme does not correct the underlying genetic cause of Pompe disease and should be administered as prescribed by your doctor.

The Treatment Experience

It is recommended that Lumizyme infusions are administered by a healthcare professional every 2 weeks, and each infusion lasts about 4 hours. You’ll be monitored during the infusion for potential life-threatening reactions. During the infusion, you can do other things such as read, watch television, or visit with family and friends. It’s a good idea to talk to your doctor before you start treatment so you know what to expect and what kind of things you should alert your healthcare team about. If you experience a severe allergic reaction during an infusion, the infusion should be discontinued and you will receive appropriate medical care.

Indication

Important Safety Information

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE

If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after Lumizyme administration.

If your child has compromised breathing or heart function due to Pompe disease, there may be a risk of acute worsening of heart and/or lung function with Lumizyme due to the fluid from the infusion, and your doctor may decide that close observation during and after Lumizyme administration may be necessary.

Warnings and Precautions

Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during and after treatment with alglucosidase alfa. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide you with immediate medical care. Appropriate medical support and monitoring measures should be available during infusion.

Immune-Mediated Reactions: You or your child may be monitored for the development of systemic immune-mediated reactions while receiving Lumizyme. If these reactions occur, your doctor may discontinue the infusion and initiate appropriate medical treatment.

Risk of Acute Cardiorespiratory Failure: Infant Pompe patients with heart or breathing
problems who are experiencing an acute respiratory condition may be at risk for increasing the seriousness of these problems as a result of Lumizyme administration due to the infusion fluid, and your child’s doctor may require additional monitoring for these infants.

Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement: Caution should be used when administering general anesthesia for the placement of a central venous catheter intended for Lumizyme infusion. Ventricular arrhythmias and slow heart rate resulting in cardiac arrest or death have been observed in infant Pompe patients with cardiac hypertrophy during general anesthesia for central venous catheter placement. Appropriate medical support and monitoring measures should be available during infusion.

Risk of Antibody Development: Patients with infantile-onset Pompe disease (IOPD) should be managed by a clinical specialist knowledgeable in immune tolerance induction in Pompe disease to optimize treatment. Some patients who develop high and sustained IgG antibody levels, including certain IOPD patients, may have a reduced response to Lumizyme.

Monitoring: Laboratory Tests: Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter.

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